Standard
In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.
According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.
In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.
International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.
Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.
- Structure:
- Chemical Name:1-Pentanone, 1-(2-hydroxy-5-methylphenyl)-
- CAS:150033-77-5
- MF:C12H16O2
- Structure:
- Chemical Name:3-methyl-2-pentylphenol
- CAS:1823068-39-8
- MF:C12H18O
- Structure:
- Chemical Name:PLSQ-001 TM4-QJ
- CAS:1227162-74-4
- MF:C18H24N2O2
- Structure:
- Chemical Name:(2S)-2-(2,5-dioxo-3-propylpyrrolidin-1-yl)butanoic acid
- CAS:2101641-92-1
- MF:C11H17NO4
- Structure:
- Chemical Name:2-Pyridineethanamine, N-methyl-N-[2-(2-pyridinyl)ethyl]-, hydrochloride (1:3)
- CAS:2095467-43-7
- MF:C15H20ClN3
- Structure:
- Chemical Name:(S)-tert-butyl (1-(3-(2-cyanobenzyl)
- CAS:1618644-31-7
- MF:C23H29N5O4
- Structure:
- Chemical Name:(S)-tert-butyl (1-(3-(2-cyanobenzyl)
- CAS:1618644-31-7
- MF:C23H29N5O4
- Structure:
- Chemical Name:Droxidopa Impurity 4
- CAS:55382-14-4
- MF:C31H29NO7
- Chemical Name:RV Salmonella enrichment broth (Pharmacopoeia 2015 edition)
- CAS:
- MF:
- Chemical Name:(1r,4r)-4-(5,6-dibromo-2-methylquinazolin-3(4H)-yl)cyclohexan-1-ol
- CAS:
- MF:
- Structure:
- Chemical Name:N-(5-(Propionyloxy)pentyl Acrylate) rac-trans-Laudanosine Benzenesulfonate
- CAS:155913-32-9
- MF:C38H49NO11S
- Structure:
- Chemical Name:1,8-ditosyl-1,4,8,11-tetraazacyclotetradecane dihydrochloride
- CAS:
- MF:C24H38Cl2N4O4S2
- Structure:
- Chemical Name:Mupirocin iMpurity 5
- CAS:
- MF:C26H44O9
- Structure:
- Chemical Name:Tolvaptan Impurity 11
- CAS:150683-27-5
- MF:C25H23ClN2O3
- Structure:
- Chemical Name:methyl 2-(4-(2-chloroacetyl)phenyl)-2-methylpropanoate
- CAS:1638785-19-9
- MF:C13H15ClO3
- Structure:
- Chemical Name:1155863-81-2
- CAS:1155863-81-2
- MF:C23H19F2N3O6
- Structure:
- Chemical Name:1175018-73-1
- CAS:1175018-73-1
- MF:C12H14ClN
- Structure:
- Chemical Name:tert-butyl (3S,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate
- CAS:
- MF:C37H43FN2O5
- Chemical Name:Nitrendipine iMpurity 3
- CAS:
- MF:
- Chemical Name:Cefminox Impurity 3
- CAS:
- MF:
- Chemical Name:Afatinib Impurity 57
- CAS:
- MF:
- Chemical Name:Afatinib Impurity 57
- CAS:
- MF:
- Structure:
- Chemical Name:Apremilast Impurity 34
- CAS:2469037-82-7
- MF:C20H20N2O7S
- Chemical Name:Aprepitant Impurity 35
- CAS:
- MF:
- Chemical Name:Bosutinib Impurity 15
- CAS:
- MF:
- Chemical Name:Ertapenem Impurity 2
- CAS:
- MF:
- Chemical Name:Febuxostat Impurity 68
- CAS:
- MF:
- Chemical Name:Indacaterol Impurity 9
- CAS:
- MF:
- Structure:
- Chemical Name:Olanzapine Impurity 22
- CAS:
- MF:C17H20N4S
- Structure:
- Chemical Name:Olopatadine Impurity 9
- CAS:680579-52-6
- MF:C39H36Br2P2
- Structure:
- Chemical Name:Clopidogrel Impurity 44
- CAS:
- MF:C15H14ClNO2S
- Structure:
- Chemical Name:5-ethyl 7-methyl 6-(2-chlorophenyl)-8-methyl-3,4,5,6-tetrahydro-2H- benzo[b][1,4]oxazine-5,7-dicarboxylate
- CAS:949155-13-9
- MF:C20H22ClNO5
- Structure:
- Chemical Name:Nifedipine impurity 06
- CAS:
- MF:C19H22N2O6
- Chemical Name:Moxifloxacin Impurity 10
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity 11
- CAS:
- MF:
- Chemical Name:Parecoxib Impurity 18
- CAS:
- MF:
- Chemical Name:Apixaban Impurity 34
- CAS:
- MF:
- Chemical Name:Teneligliptin Impurity 9 DiHCl
- CAS:
- MF:
- Chemical Name:Pramipexole Impurity Z2
- CAS:
- MF:
- Structure:
- Chemical Name:monocalciummono(4-(((2R,4R)-1-([1,1'-biphenyl]-4-yl)-5-ethoxy- 4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoate)
- CAS:
- MF:C24H28CaNO5
- Chemical Name:Aprepitant iMpurity 40
- CAS:
- MF:
- Chemical Name:Aprepitant iMpurity43
- CAS:
- MF:
- Structure:
- Chemical Name:1-Propanamine, 3-(diphenylphosphinyl)-N,N-dimethyl-
- CAS:962-95-8
- MF:C17H22NOP
- Chemical Name:Afatinib Impurity ODQ
- CAS:
- MF:
- Chemical Name:Afatinib Impurity ODQ
- CAS:
- MF:
- Structure:
- Chemical Name:Afatinib Impurity QJJ
- CAS:2323570-72-3
- MF:C24H27ClFN5O4
- Structure:
- Chemical Name:Afatinib Impurity QJJ
- CAS:2323570-72-3
- MF:C24H27ClFN5O4
- Structure:
- Chemical Name:Cabozantinib Impurity 50
- CAS:202917-05-3
- MF:C17H14N2O5
- Chemical Name:Landiolol impurity U
- CAS:
- MF:
- Chemical Name:Teneligliptin Impurity 15
- CAS:
- MF:
- Chemical Name:Nicergoline EP Impurity I
- CAS:
- MF:
- Structure:
- Chemical Name:Carbamic acid, N-[(4-methylphenyl)sulfonyl]-
- CAS:107628-27-3
- MF:C8H9NO4S
- Structure:
- Chemical Name:9H-Purin-6-amine, 9-(2-chloropropyl)-
- CAS:50615-40-2
- MF:C8H10ClN5
- Chemical Name:Hyoscine Butylbromide EP Impurity G
- CAS:
- MF:
- Chemical Name:tirofiban Impurity 1 DIHCl
- CAS:
- MF:
- Structure:
- Chemical Name:Fingolimod 2-Phenethyl Analog
- CAS:851039-25-3
- MF:C35H57NO2
- Structure:
- Chemical Name:Ritonavir EP Impurity O
- CAS:1414933-81-5
- MF:C37H48N6O5S2
- Structure:
- Chemical Name:Entecavir Impurity 17(Entecavir EP Impurity C)
- CAS:2204369-23-1
- MF:C12H15N5O4
- Structure:
- Chemical Name:Gemcitabine Impurity 9
- CAS:2174019-90-8
- MF:C16H15F2N3O5
- Structure:
- Chemical Name:Sacubitril
- CAS:1361408-17-4
- MF:C18H20ClNO2
- Chemical Name:Empagliflozin Impurity 43
- CAS:
- MF:
- Structure:
- Chemical Name:1-tosyl-1,4,8,11-tetraazacyclotetradecane trihydrochloride
- CAS:128495-30-7
- MF:C17H31ClN4O2S
- Structure:
- Chemical Name:Oseltamivir Impurity 59
- CAS:2485836-60-8
- MF:C12H22N2O3
- Chemical Name:Palbociclib Impurity 36
- CAS:
- MF:
- Chemical Name:Regorafenib Impurity 34
- CAS:
- MF:
- Chemical Name:Rosuvastatin Impurity 47
- CAS:
- MF:
- Structure:
- Chemical Name:Sildenafil Impurity 36
- CAS:
- MF:C25H27N3O5
- Chemical Name:Sunitinib Impurity 4
- CAS:
- MF:
- Chemical Name:Tafluprost Impurity 11
- CAS:
- MF:
- Chemical Name:Tazobactam Impurity 4
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity 103
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity 94
- CAS:
- MF:
- Chemical Name:Tofacitinib Impurity 119
- CAS:
- MF:
- Chemical Name:Trelagliptin Impurity 26
- CAS:
- MF:
- Chemical Name:Trelagliptin Impurity 31
- CAS:
- MF:
- Chemical Name:Caspofungin impurity E
- CAS:
- MF:
- Chemical Name:Erythromycin Impurity C
- CAS:
- MF:
- Chemical Name:Itraconazole iMpurity 4
- CAS:
- MF:
- Chemical Name:Azacitidine Impurity 3
- CAS:
- MF:
- Chemical Name:Ozagrel Impurity 2
- CAS:
- MF:
- Chemical Name:Olaparib Impurity 22
- CAS:
- MF:
- Structure:
- Chemical Name:Irbesartan Impurity 14
- CAS:133690-91-2
- MF:C25H28N6O
- Structure:
- Chemical Name:Febuxostat Impurity 25
- CAS:1643131-89-8
- MF:C17H20N2O4S
- Structure:
- Chemical Name:Pregabalin Impurity 3
- CAS:1928754-83-9
- MF:C12H22O3
- Chemical Name:Bosutinib Impurity 6
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity 49
- CAS:2376278-80-5
- MF:
- Chemical Name:Edoxaban Impurity 14
- CAS:
- MF:
- Structure:
- Chemical Name:Indacaterol Impurity 3
- CAS:2250243-41-3
- MF:C26H32N2O3
- Chemical Name:Canagliflozin Impurity 11
- CAS:
- MF:
- Chemical Name:Oseltamivir Impurity 22
- CAS:
- MF:
- Chemical Name:Riociguat IMpurtiy B
- CAS:
- MF:
- Structure:
- Chemical Name:Amlodipine Impurity 48
- CAS:39562-06-6
- MF:C18H20ClNO4
- Chemical Name:Silodosin Impurity C
- CAS:
- MF:
- Structure:
- Chemical Name:Dexmedetomidine-025
- CAS:2250242-52-3
- MF:C20H22N2
- Chemical Name:pranoprofen impurity 15
- CAS:
- MF:
- Structure:
- Chemical Name:Mono-Hydroxy Sugammadex
- CAS:2376607-99-5
- MF:C69H109NaO47S7
- Chemical Name:Metronidazole impurity A
- CAS:
- MF:
- Chemical Name:Sulpiride Impurity 6
- CAS:
- MF:
- Chemical Name:Cefminox Impurity A
- CAS:
- MF:
- Chemical Name:Cefminox Impurity F
- CAS:
- MF: